Endocyte’s EC145 Produces Significant Anti-Tumor Activity In Advanced Stage Chemoresistant Ovarian Cancer Patients

Endocyte, Inc., … presented data from a Phase 2a clinical trial for EC145, … In 49 women with advanced-stage ovarian cancer, EC145 was shown to have anti-tumor activity in a significant percentage of participants in the trial. …[T]he overall disease control rate, defined as stable disease, partial or complete response to therapy, was 40.8 percent (20 of 49). … In the subgroup of patients who were EC20 “positive” and who had failed four or fewer prior therapies, the disease control rate was 75 percent (9 of 12) and two patients exhibited a RECIST partial response. …

EC20 Imaging Results

Companion diagnostic images of ovarian cancer patients using folate-receptor targeted imaging agent (EC20-Tc99m). Patient on the top shows no targeting to tumor (negative profile). Patient on the bottom shows targeting to tumor (positive profile)(Photo: Endocyte, Inc.)

Endocyte, Inc., a cancer drug discovery and development company, presented data from a Phase 2a clinical trial for EC145, currently in development as a potential treatment for advanced ovarian cancer. Results were presented at the European Society of Gynaecologic Oncology (ESGO) meeting in Belgrade, Serbia last week. In 49 women with advanced-stage ovarian cancer, EC145 was shown to have anti-tumor activity in a significant percentage of participants in the trial.

The study participants had disease that was highly resistant to standard chemotherapy. Subjects had a median of four prior exposures to chemotherapy (with a range of 1 to 14), and 88 percent were diagnosed with “bulky disease,” defined as having a tumor volume of greater than five centimeters in diameter. However, in spite of this, the overall disease control rate, defined as stable disease, partial or complete response to therapy, was 40.8 percent (20 of 49).

Prior to the start of treatment with EC145, the women were scanned with 99mTc-EC20 [EC20], a molecular imaging agent that binds to folate receptors (FR) and is being developed by Endocyte as a companion diagnostic tool to identify patients whose tumors express FR, the molecular target for the EC145 therapy. When scanned with EC20, 76 percent of patients were found to be folate-receptor “positive.” In the subgroup of patients who were EC20 “positive” and who had failed four or fewer prior therapies, the disease control rate was 75 percent (9 of 12) and two patients exhibited a RECIST partial response. Across all patients, the drug was well tolerated with no grade 4 toxicities. The most common grade 3 toxicity was fatigue (8.2 percent).

According to Dr. Richard Messmann, Endocyte’s VP for medical affairs, “These preliminary results provide significant additional support for Endocyte’s technology platform and for the important role that Endocyte’s co-development of targeted therapeutics and companion diagnostics can play in cancer drug discovery. Based upon these promising results, EC145 is now being evaluated in our Phase 2b PRECEDENT study, an international randomized study of EC145 in combination with Doxil®/Caelyx® versus Doxil®/Caelyx® alone in women with platinumresistant ovarian cancer.”

About Endocyte

EC145 PRECEDENT Clinical TrialEndocyte is a privately held biotechnology company with headquarters in the Purdue Research Park of West Lafayette, IN. Based on the applications of Endocyte’s advanced proprietary Drug Guidance System (DGS), the company is working to develop new drugs and diagnostic agents to treat many types of cancer and other serious diseases. The DGS platform makes it possible to use highly potent drugs on extended and frequent dosing schedules and in combination with other drugs to maximize efficacy. The technology improves drug targeting and reduces the risk of side effects by combining drugs with ligands that are able to identify and attach to receptors found on tumor and other disease cells. Endocyte’s clinical development of EC20 and EC145 is progressing with the recent completion of accrual for the Phase 2a trials in advanced ovarian and lung cancer. EC20 and EC145 are now being studied in an international Phase 2b trial of EC145 in combination with Doxil® for the treatment of women with platinum resistant ovarian cancer. Other clinical-stage products in the Endocyte pipeline include EC0225, a targeted combination of two potent anticancer drugs; BMS753493, a potent drug being developed in partnership with Bristol-Myers Squibb; EC0489, a targeted cancer drug; and EC17, a targeted immunotherapy agent. The company also has multiple product candidates in pre-clinical stage of development.

Information about the PRECEDENT study can be found at http://clinicaltrials.gov/ct2/show/NCT00722592.

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Endocyte Begins Phase II Clinical Trial of EC145 for Treatment of Women with Platinum Resistant Ovarian Cancer

Endocyte Inc. has announced the initiation of a randomized Phase II clinical study of the company’s investigational drug EC145 in women with platinum-resistant ovarian cancer. The phase II trial, also called the “PRECEDENT study,” will evaluate the efficacy and safety of EC145 when administered in combination with pegylated liposomal doxorubicin (PLD). …The PRECEDENT study will enroll 122 subjects and involve more than 50 clinical centers in the U.S., Canada, and Europe. … EC145 links a very potent anticancer drug to the vitamin folate, which is required for cell division. Rapidly dividing cancer cells over-express folate receptors to capture enough folate to support cell division. By combining a chemotherapy drug with folate, EC145 targets cancer cells while avoiding normal cells. This targeted approach is designed to provide treatment with more potent drugs with lower toxicity.”

″WEST LAFAYETTE, IN. – February 19, 2009 – Endocyte Inc. has announced the initiation of a randomized Phase II clinical study of the company’s investigational drug EC145 in women with platinumresistant ovarian cancer. The phase II trial, also called the “PRECEDENT study,” will evaluate the efficacy and safety of EC145 when administered in combination with pegylated liposomal doxorubicin (PLD).  PLD is widely used as a standard therapy for women with platinum-resistant ovarian cancer. The efficacy and safety of the combination of EC145/PLD  will be compared to treatment with PLD without EC145. Ovarian cancer is the fifth most common cancer among women in the United States and the leading cause of death due to cancer of the female reproductive system. The PRECEDENT study will enroll 122 subjects and involve more than 50 clinical centers in the U.S., Canada, and Europe. Trial details can be found at www.endocyte.com and http://www.clinicaltrials.gov.  EC145 links a very potent anticancer drug to the vitamin folate, which is required for cell division. Rapidly dividing cancer cells over-express folate receptors to capture enough folate to support cell division. By combining a chemotherapy drug with folate, EC145 targets cancer cells while avoiding normal cells. This targeted approach is designed to provide treatment with more potent drugs with lower toxicity.

  Advanced Ovarian Cancer - Imaging folate-receptors cancer cells using EC20 (folate-Tc99m). Source:  Endocyte

Advanced Ovarian Cancer - Imaging folate-receptors cancer cells using EC20 (folate-Tc99m). Source: Endocyte

In addition to EC145, patients in the PRECEDENT trial will also be treated with a new molecular imaging agent called EC20 developed by Endocyte. By targeting folate receptors, EC20 imaging agent allows clinicians to identify tumors that overexpress the folate receptor. Using EC20, doctors may be able to identify, in advance, those patients who will benefit from EC145 therapy. According to Dr. Wendel Naumann of the Blumenthal Cancer Center, Carolinas Medical Center and principal investigator for the PRECEDENT study, ‘Patients with advanced, platinum resistant, ovarian cancer are in need of therapy that does not result in significant toxicity. The earlier clinical studies of EC145 were encouraging because they indicated that clinicians could use EC20 to identify women whose tumors expressed the molecular target of EC145. Therapy with EC145 might benefit these patients without causing significant additional toxicity.’ ‘The start of the PRECEDENT study is another important validation of Endocyte’s promising DGS [Drug Guidance System] technology platform,” said Dr. Richard Messmann, Endocyte’s vice president for medical affairs. ‘This also represents an important milestone in Endocyte’s efforts to develop a range of new drugs and predictive medicine tools to treat cancer and other serious diseases in the years ahead. ‘

About Endocyte
Endocyte is a privately-held biotechnology company with headquarters in the Purdue Research Park of West Lafayette, IN. Based on the applications of Endocyte’s advanced proprietary Drug Guidance System (DGS), the Company is working to develop new drugs and diagnostic agents to treat many types of cancer and other serious diseases. The DGS platform makes it possible to use highly-potent drugs on extended and frequent dosing schedules and in combination with other drugs to maximize efficacy. The technology improves drug targeting and reduces the risk of side effects by combining drugs with ligands that are able to identify and attach to receptors found on tumor and other disease cells. Endocyte is currently conducting three separate Phase 2 clinical trials for its lead compound, EC145, together with EC20, a companion molecular imaging agent, for the treatment of ovarian cancer and non-small cell lung cancer. Other clinical-stage products in the Endocyte pipeline include: EC0225, a combination of two potent anticancer drugs; BMS493, a potent drug being developed in partnership with Bristol-Myers Squibb; EC17, a targeted immunotherapy agent; and EC0489, a targeted cancer drug. The Company also has multiple product candidates in pre-clinical stage development.  This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve significant risks and uncertainties that may cause results to differ materially from those set forth in the statements. We undertake no obligation to publicly update any forwardlooking statement, whether as a result of new information, future events, or otherwise.

Contacts:
Vickey Buskirk, media relations, Endocyte Inc., (765) 463-7175 ext. 1117, vbuskirk@endocyte.com”

Quoted Source: ENDOCYTE BEGINS PHASE II CLINICAL TRIAL OF EC145 FOR TREATMENT OF WOMEN WITH OVARIAN CANCER, News Release, February 19, 2009 (PDF Document).

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